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Synergy Announces Positive Results From Plecanatide Phase IIb/III Trial in Patients With Chronic Idiopathic Constipation

Synergy Announces Positive Results From Plecanatide Phase IIb/III Trial in
Patients With Chronic Idiopathic Constipation

  Topline Data Show That Plecanatide Met Primary and Key Secondary Endpoints

NEW YORK, Jan. 2, 2013 (GLOBE NEWSWIRE) -- Synergy Pharmaceuticals, Inc.
(Nasdaq:SGYP) today announced that plecanatide, its investigational oral drug
for the treatment of chronic idiopathic constipation (CIC), was well tolerated
and met the primary and key secondary endpoints of a Phase IIb/III clinical
study. Full study results will be presented at a major scientific meeting this
year.

The randomized, double-blind, placebo-controlled, repeat-dose, dose-ranging
study was designed to determine whether plecanatide could increase the number
of complete spontaneous bowel movements (CSBM's) and impact other parameters
such as stool consistency, straining and time to first bowel movement in
patients with CIC. The 12-week study, which included 951 CIC patients at 113
clinical sites in the United States, evaluated 3 doses of plecanatide (0.3,
1.0, 3.0 mg) plus a placebo arm.

Evidence of increasing efficacy was seen at increasing dose levels. Notably,
the 3 mg dose in the current trial demonstrated a 19% (p=0.009) overall
responder rate (vs. placebo of 10.7%), as well as demonstrating a mean
increase in CSBMs over the 12-week treatment period of 2.13 (p<0.001). In
addition, statistically significant improvements were seen in key secondary
endpoints.The incidence of diarrhea at 3 mg was observed to be 9.7% (vs.
placebo incidence of 1.3%).

"We look forward to presenting the full results of this clinical study, which
confirmed the efficacy and safety of plecanatide," said Dr. Gary S. Jacob,
President and CEO of Synergy Pharmaceuticals. "This trial also represents a
major milestone for Synergy. We pioneered the study of analogs of the human
hormone uroguanylin to treat gastrointestinal disorders in an effort to
identify an agent that would normalize bowel movements with minimal
diarrhea."

"Based on the results of this trial, we are convinced that plecanatide has the
potential to be a safe, effective and much-needed new treatment for millions
of patients who are living with chronic constipation," Dr. Jacob added.

The study, which concluded late, last month, was part of an ongoing CIC
development program for plecanatide.Synergy is also conducting a Phase IIb
study to assess plecanatide in the treatment of irritable bowel syndrome with
constipation (IBS-C).In addition, a Phase I study was recently completed with
Synergy's second GC-C agonist, known as SP-333, for the treatment of
inflammatory bowel diseases.

About Chronic Constipation

Chronic constipation is the most common digestive complaint in the United
States and the world.About 15%, or 45 million people, suffer from chronic
constipation in the U.S., with a similar prevalence in other developed
countries.Although chronic constipation affects both men and women of every
age, it disproportionately impacts women as well as the elderly, a large and
growing population.

Current treatments provide temporary relief, but because they fail to address
the underlying causes of chronic constipation, they do not normalize patients'
bowel function. Such treatments are also associated with unpleasant side
effects, the most common of which is diarrhea, causing patients to see-saw
between extremes.As a result, most doctors and their patients are
dissatisfied with current treatments for chronic constipation.

Chronic constipation is also a significant driver of healthcare
costs.Healthcare systems are spending millions of dollars annually to
diagnose and treat this disorder, including $820 million annually on
over-the-counter laxatives in the U.S. alone.

About Plecanatide

Plecanatide is a member of a new class of essentially non-systemic drugs,
referred to as guanylate cyclase C (GC-C) agonists, which are currently in
development to treat CIC and IBS-C. Plecanatide is a synthetic analog of
uroguanylin, a natriuretic hormone that regulates ion and fluid transport in
the GI tract. Orally-administered plecanatide binds to and activates GC-C
receptors expressed on epithelial cells lining the GI mucosa, resulting in
activation of the cystic fibrosis transmembrane conductance regulator (CFTR),
and leading to augmented flow of chloride and water into the lumen of the gut.
Activation of the GC-C receptor pathway is believed to facilitate bowel
movement as well as producing other beneficial physiological responses
including improvement in abdominal pain and inflammation. In animal models,
oral administration of plecanatide promotes intestinal secretion and also
ameliorates GI inflammation.

About Synergy Pharmaceuticals Inc.

Synergy is a biopharmaceutical company focused on the development of new drugs
to treat gastrointestinal disorders and diseases. Synergy's lead proprietary
drug candidate plecanatide is a synthetic analog of the human gastrointestinal
hormone uroguanylin, and functions by activating the guanylate cyclase C
receptor on epithelial cells of the GI tract. Synergy completed a Phase I
study of plecanatide in healthy volunteers, a Phase IIa clinical trial in CIC
patients, and has just completed a major Phase IIb/III clinical trial of
plecanatide to treat CIC. Plecanatide is also being developed to treat IBS-C,
with the first trial in IBS-C patients initiated in the fourth quarter of
2012. Synergy's second GC-C agonist SP-333 is in clinical development to treat
inflammatory bowel diseases, and has just completed its first Phase I trial in
healthy volunteers. More information is available at
http://www.synergypharma.com.

Forward-Looking Statements

Certain statements in this press release are forward-looking within the
meaning of the Private Securities Litigation Reform Act of 1995. These
statements may be identified by the use of forward-looking words such as
"anticipate," "planned," "believe," "forecast," "estimated," "expected," and
"intend," among others. These forward-looking statements are based on
Synergy's current expectations and actual results could differ materially.
There are a number of factors that could cause actual events to differ
materially from those indicated by such forward-looking statements. These
factors include, but are not limited to, substantial competition; our ability
to continue as a going concern; our need for additional financing;
uncertainties of patent protection and litigation; uncertainties of government
or third party payer reimbursement; limited sales and marketing efforts and
dependence upon third parties; and risks related to failure to obtain FDA
clearances or approvals and noncompliance with FDA regulations. As with any
pharmaceutical under development, there are significant risks in the
development, regulatory approval and commercialization of new products. There
are no guarantees that future clinical trials discussed in this press release
will be completed or successful or that any product will receive regulatory
approval for any indication or prove to be commercially successful. Investors
should read the risk factors set forth in Synergy's Form 10-K for the year
ended December 31, 2011 and other periodic reports filed with the Securities
and Exchange Commission. While the list of factors presented here is
considered representative, no such list should be considered to be a complete
statement of all potential risks and uncertainties. Unlisted factors may
present significant additional obstacles to the realization of forward-looking
statements. Forward-looking statements included herein are made as of the date
hereof, and Synergy does not undertake any obligation to update publicly such
statements to reflect subsequent events or circumstances.

CONTACT: Media Contact:
         Janet Skidmore
         Office: 215-658-4915
         Mobile: 215-429-2917
         skidmorecomm@earthlink.net
        
         Investor Contact:
         Danielle Spangler
         The Trout Group
         synergy@troutgroup.com
         (646) 378-2924
 
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